NCT06705868: CHRONOMASLD

Chrononutrition/ Chronotoxicity Intervention in People With Metabolic-associated Steatotic Liver Disease.

Not yet recruiting NA Last updated 19 November 2025

What this trial tests

NA trial testing Diet-Time-restricted eating (TRE) in MASLD in 150 participants. Not yet recruiting.

Timeline

5 January 2026

Primary endpoint
15 December 2027

15 December 2029

Quick facts

Lead sponsor	Cyprus University of Technology
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	5 January 2026
Primary completion	15 December 2027
Estimated completion	15 December 2029
Sites	1 location across Cyprus

Drugs / interventions tested

• Diet-Time-restricted eating (TRE)
• Lifestyle Management — full drug profile →

Conditions studied

• MASLD — all drugs for MASLD →
• MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease — all drugs for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease →
• NAFLD — all drugs for NAFLD →
• NAFLD - Non-Alcoholic Fatty Liver Disease — all drugs for NAFLD - Non-Alcoholic Fatty Liver Disease →

Sponsor

Cyprus University of Technology

Who can join

Adults 18 to 70, any sex, with MASLD or MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to study the effect of a time-restricted eating (TRE) dietary pattern combined with a time of consumption restriction about the daily portions of fruits and vegetables in people diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).

The protocol of the study is an intention to treat protocol. The main research questions are:

1. Does compliance in a TRE dietary scheme (positively) affect changes in body weight and body fat mass in people diagnosed with MASLD?
2. Does an additional time restriction on the consumption of fruits and vegetables within the "light-window" of the day affects the metabolism of food contaminants?

Participants will be asked to:

1. Adhere to a TRE dietary pattern for 3 months. TRE consists of an 8-hour eating vs 16 hours fasting within the day. First meal of the day should not occur at least an hour after wake-up time and last meal of the day should occur not later than 2 hours before bed-time.
2. Adhere to a further time restricted consumption of a "5-a-day" portions of fruits and vegetables between the "light-window hours" between 9am to 4pm.
3. Visit the Nutrition \& Dietetics Clinic once every month for anthropometric measurements (on 4 time points).
4. Collect and deliver first morning urine samples (on 7 time points).
5. Collect and deliver saliva samples at baseline and at the end of the trial (Saliva collection should occur every 4-hours for 48-hours including fasting collection at baseline and at the end of three months)

5\) Complete a compliance and lifestyle questionnaire questionnaire via telephone interview to the research team every 2 weeks.

6\) Share photos to the research team with the use of an application on time of actual fruit and vegetables consumption, 3-4 times per week throughout the study protocol.

Researchers will compare the designed intervention package of this TRE with the Standard of Care (SoC) protocol (based on the international guidelines) that is currently used in daily practice for the management of MASLD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tuned by time: the role of circadian rhythms in metabolic energy sensing and chronotherapy.
   Thanuskodi Rajakumar A, Kodiveri Muthukaliannan G. · · 2025 · PMID 41339276 · DOI 10.1080/07853890.2025.2596548